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The goal of this research is to show that a shorter duration of two antiplatelet medications (compared to the standard of care) is safe and effective while reducing the risk of bleeding complications. Bleeding complications can cause significant problems (hospitalizations, need for blood transfusions, and even death) for patients on antiplatelet medications after coronary stents. Researchers hope to show that reducing the time on two antiplatelet agents in patients at high risk for these bleeding complications will reduce the number of bleeding events while not causing any increase in cardiovascular complications (heart attack, stent malfunction, death).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Genotype-Guided Therapy | Experimental | Subjects with high bleeding risk (HBR) on dual antiplatelet therapy (DAPT) with clopidogrel and aspirin, that have undergone successful percutaneous coronary intervention (PCI) will be stratified by the CYP2C19 loss-of-function (LOF) allele within one week of DAPT initiation. In this group, subjects identified as CYP2C19*2 or*3 LOF allele carrier will be given prasugrel or ticagrelor monotherapy. |
|
| Conventional Therapy | Active Comparator | Subjects with high bleeding risk (HBR) on dual antiplatelet therapy (DAPT) with clopidogrel and aspirin, that have undergone successful percutaneous coronary intervention (PCI) will be stratified by the CYP2C19 loss-of-function (LOF) allele within one week of DAPT initiation. In this group, subjects identified as CYp2C19*2 or*3 LOF allele non-carriers will continue with clopidogrel monotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clopidogrel | Drug | 75 mg/day |
| |
| Prasugrel |
| Measure | Description | Time Frame |
|---|---|---|
| Ischemic Risk Post-PCI in High Bleed Risk Patients With Genotype-guided Single Antiplatelet Therapy | The number of participants to experience ischemic events as defined as cardiac deaths, spontaneous myocardial infarctions (MIs) and stent thrombosis after percutaneous intervention (PCI). | Through study completion, approximately 90 days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mandeep Singh, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39601743 | Derived | Ingraham BS, Huxley SB, Lane CM, Gulati R, Lewis BR, Jaffe AS, Bell MR, Lerman A, Pereira NL, Moyer AM, Baudhuin LM, Rihal CS, Singh M. Genotype-Guided P2Y12 Inhibitor Monotherapy Within 7 Days of Percutaneous Coronary Intervention in High Bleeding Risk Patients: The CHAMP Trial - A Pilot Study and Safety Assessment. Mayo Clin Proc. 2025 Jan;100(1):94-108. doi: 10.1016/j.mayocp.2024.05.030. Epub 2024 Nov 26. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Genotype-Guided Therapy | Subjects with high bleeding risk (HBR) on dual antiplatelet therapy (DAPT) with clopidogrel and aspirin, that underwent successful percutaneous coronary intervention (PCI) were stratified by the CYP2C19 loss-of-function (LOF) allele within one week of DAPT initiation. In this group, subjects identified as CYP2C19*2 or*3 LOF allele carrier were given prasugrel or ticagrelor monotherapy. Prasugrel: 60 mg bolus then 10 mg daily Tricagrelor: 180 mg bolus then 90 mg twice daily |
| FG001 | Conventional Therapy | Subjects with high bleeding risk (HBR) on dual antiplatelet therapy (DAPT) with clopidogrel and aspirin, that underwent successful percutaneous coronary intervention (PCI) were stratified by the CYP2C19 loss-of-function (LOF) allele within one week of DAPT initiation. In this group, subjects identified as CYp2C19*2 or*3 LOF allele non-carriers continued with clopidogrel monotherapy. Clopidogrel: 75 mg/day |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Genotype-Guided Therapy | Subjects with high bleeding risk (HBR) on dual antiplatelet therapy (DAPT) with clopidogrel and aspirin, that underwent successful percutaneous coronary intervention (PCI) were stratified by the CYP2C19 loss-of-function (LOF) allele within one week of DAPT initiation. In this group, subjects identified as CYP2C19*2 or*3 LOF allele carrier were given prasugrel or ticagrelor monotherapy. Prasugrel: 60 mg bolus then 10 mg daily Tricagrelor: 180 mg bolus then 90 mg twice daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Ischemic Risk Post-PCI in High Bleed Risk Patients With Genotype-guided Single Antiplatelet Therapy | The number of participants to experience ischemic events as defined as cardiac deaths, spontaneous myocardial infarctions (MIs) and stent thrombosis after percutaneous intervention (PCI). | Posted | Count of Participants | Participants | Through study completion, approximately 90 days. |
|
Adverse Events were collected from baseline to end of study, approximately 90 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Genotype-Guided Therapy | Subjects with high bleeding risk (HBR) on dual antiplatelet therapy (DAPT) with clopidogrel and aspirin, that underwent successful percutaneous coronary intervention (PCI) were stratified by the CYP2C19 loss-of-function (LOF) allele within one week of DAPT initiation. In this group, subjects identified as CYP2C19*2 or*3 LOF allele carrier were given prasugrel or ticagrelor monotherapy. Prasugrel: 60 mg bolus then 10 mg daily Tricagrelor: 180 mg bolus then 90 mg twice daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Possible Stent Thrombosis | Vascular disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| BARC 3 bleeding event | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mandeep Singh, M.D. | Mayo Clinic | 507-255-2398 | Singh.Mandeep@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 1, 2023 | Feb 12, 2024 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D000077144 | Clopidogrel |
| D000068799 | Prasugrel Hydrochloride |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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| Drug |
60 mg bolus then 10 mg daily |
|
| Tricagrelor | Drug | 180 mg bolus then 90 mg twice daily |
|
| BG001 | Conventional Therapy | Subjects with high bleeding risk (HBR) on dual antiplatelet therapy (DAPT) with clopidogrel and aspirin, that underwent successful percutaneous coronary intervention (PCI) were stratified by the CYP2C19 loss-of-function (LOF) allele within one week of DAPT initiation. In this group, subjects identified as CYp2C19*2 or*3 LOF allele non-carriers continued with clopidogrel monotherapy. Clopidogrel: 75 mg/day |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Conventional Therapy | Subjects with high bleeding risk (HBR) on dual antiplatelet therapy (DAPT) with clopidogrel and aspirin, that underwent successful percutaneous coronary intervention (PCI) were stratified by the CYP2C19 loss-of-function (LOF) allele within one week of DAPT initiation. In this group, subjects identified as CYp2C19*2 or*3 LOF allele non-carriers continued with clopidogrel monotherapy. Clopidogrel: 75 mg/day |
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | Conventional Therapy | Subjects with high bleeding risk (HBR) on dual antiplatelet therapy (DAPT) with clopidogrel and aspirin, that underwent successful percutaneous coronary intervention (PCI) were stratified by the CYP2C19 loss-of-function (LOF) allele within one week of DAPT initiation. In this group, subjects identified as CYp2C19*2 or*3 LOF allele non-carriers continued with clopidogrel monotherapy. Clopidogrel: 75 mg/day | 0 | 69 | 1 | 69 | 3 | 69 |
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| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010879 | Piperazines |